Clinical trials: Psilocybin
Depressive Disorder
Psilocybe Cubensis Mushrooms With or Without Fluoxetine for Refractory Depression
This Phase 2a pilot, exploratory, randomized, double-blind, placebo-controlled, parallel-group trial will estimate whether concurrent fluoxetine alters the antidepressant effect, acute psychedelic experience, or safety of a…
- Trial name
- COGUNILA (NCT06898606)
- Testing
- Psilocybin and Psilocyn, Psychotherapy-assisted session, Fluoxetine
- Where
- Brazil
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Federal University of Latin American Integration
Demoralization
Exploratory Study of Low Dose Psilocybin
The purpose of the present study is to evaluate the feasibility, initial signals of efficacy, and potential mechanisms of action of "microdoses" of psilocybin (i.e., low doses of psilocybin that are not believed to produce…
- Trial name
- NCT05227742
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Healthy Volunteers
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of MLS101 in Healthy Participants
MLS101 is being developed as a low dose psilocybin, that can be administered to treat neurological and psychiatric conditions. The purpose of this clinical trial is to assess how safe and tolerated MLS101 is; to see how MLS101 is…
- Trial name
- NCT06643637
- Testing
- Psilocybin
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- MycoMedica Life Sciences PBC
Prolonged Grief Disorder
Psilocybin for Prolonged Grief Disorder
The primary purpose of this study is to explore the feasibility of conducting a clinical trial on the effects of psilocybin for individuals with prolonged grief disorder (PGD).
- Trial name
- NCT06724289
- Testing
- Psilocybin 25 mg, Functional Magnetic Resonance Imaging (fMRI)
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Chronic Low Back Pain (CLBP), Physical Therapy
Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain
The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical…
- Conditions
- Chronic Low Back Pain (CLBP), Physical Therapy, Psilocybin
- Trial name
- NCT07306364
- Testing
- Psilocybin 10 mg, Psilocybin 25 mg, Niacin 100 mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Yale University
Psilocybin, Music Intervention
PRoMiSS: Psilocybin and the Role of Music in Set and Setting
The goal of this clinical trial is to understand how personally meaningful, autobiographically salient music compares to standardized playlists when combined with psilocybin in healthy adults ages 21 to 75.
- Trial name
- PRoMiSS (NCT07180108)
- Testing
- Psilocybin (high dose), Playlist 1, Playlist 2
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Healthy
Effects of Psilocybin on Behavior, Psychology and Brain Function in Long-term Meditators
This is a double-blind placebo-controlled study investigating the acute and persisting effects of psilocybin on meditation, spirituality, health, well-being, prosocial attitudes, and brain functioning.
- Trial name
- NCT02145091
- Testing
- Moderately-high dose of psilocybin, Moderately-low dose of psilocybin, Very-low dose of psilocybin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Caregiver Distress
Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) Therapy for Caregivers of Patients With Advanced Cancer
The PEARL-C1 trial is a phase II open-label trial. Participants will receive a single high-dose (25 mg) of psilocybin in the context of Psilocybin-assisted Existential, Attachment and RelationaL (PEARL) therapy.
- Trial name
- PEARL-C1 (NCT07048743)
- Testing
- Psilocybin
- Where
- Canada
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University Health Network, Toronto
Healthy Adults
Changes in Self-awareness Induced by Psychoactive Substances: an Experimental Study With Psilocybin.
Self-awareness, the capacity of becoming the object of one's own awareness, is a frontier of scientific knowledge. Over centuries, distinct philosophical and religious traditions have grappled with the subject, but only recently…
- Trial name
- NCT07732166
- Testing
- Psilocybin (Usona Institute), Niacin 100 mg
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Pontifícia Universidade Católica do Rio de Janeiro
Healthy
Comparative Acute Effects of LSD, Psilocybin and Mescaline
LSD, psilocybin and mescaline are widely used for recreational and ethnomedical purposes. All three substances are thought to induce prototypical psychedelic effects primarily via stimulation of the 5-HT2A receptor.
- Trial name
- LPM (NCT04227756)
- Testing
- LSD, Psilocybin, Mescaline
- Where
- Switzerland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- University Hospital, Basel, Switzerland
Depression - Major Depressive Disorder, Anhedonia
Elucidating the Relevance of the Psychedelic Experience to Psilocybin's Anti-Anhedonic Effects
The goal of this clinical trial is to systematically categorize potential prohedonic effects of psilocybin in patients with anhedonia in depression. The main questions it aims to answer are: Primary Objectives 1.
- Trial name
- NCT07490353
- Testing
- Psilocybin (Usona Institute), Risperidone 1 MG, MRI
- Where
- Austria
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Medical University of Vienna
Aging
Investigating the Persisting Effects of a Single Dose of Psilocybin on Structural Plasticity in Healthy Older Adults
Participants in this study will undergo a series of non-invasive tests and activities designed to understand how a single dose of psilocybin might influence cognition and emotional well-being in healthy older adults.
- Trial name
- NCT06367738
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of California, Berkeley
Psychedelic Experiences, Amnesia
Pilot RECAP Study in Healthy Volunteers
The primary objective of the RECAP Study Program is to investigate the role played by conscious experience in the antidepressant effects of the psychedelic agent psilocybin.
- Trial name
- RECAP (NCT04842045)
- Testing
- Psilocybin and Midazolam
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- University of Wisconsin, Madison
Healthy Controls
Identification of a Safe and Non-Psychedelic Dose of Psilocybin
This randomized, double-blind, placebo-controlled, single ascending dose study will evaluate psilocybin in healthy adult subjects.
- Trial name
- NCT07710027
- Where
- Canada
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Diamond Therapeutics Inc.
Healthy
Does Serotonin System Stimulation Increase Pro-social Behavior? - A Comparative Pharmacological Neuroscientific Study in Healthy Humans
The study looks into whether administering psychedelic substances that stimulate the serotonin system influences pro-social behavior when compared to administering substances that stimulate the dopamine system in healthy…
- Trial name
- NCT06081179
- Testing
- Psilocybin, 3,4 Methylenedioxymethamphetamine, Methylphenidate
- Where
- Switzerland
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- University of Zurich
Aging, Longevity
Psilocybin Effects on Healthy Aging Biomarkers and Purpose in Life
The LONG-LIFE study is a randomized Phase I, dose-ranging trial designed to evaluate whether psilocybin impacts aging-related biomarkers, cognitive function, and purpose/meaning in life in medically stable older adults.
- Conditions
- Aging, Longevity, Biomarkers of Aging
- Trial name
- LONG-LIFE (NCT07719088)
- Testing
- Psilocybin (Usona Institute)
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Charles Raison
Healthy
Effects of Psilocybin-facilitated Experience on the Psychology and Effectiveness of Professional Leaders in Religion
The current protocol is a pilot study of the effects and possible utility of psilocybin-facilitated experiences for professional religious leaders.
- Trial name
- NCT02243813
- Testing
- Psilocybin
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Johns Hopkins University
Phase I
Pilot Study on the Effects of Psilocybin on Belief Updating and Insight Formation
The primary aim of this phase I mechanistic pilot study is to evaluate the effects of psilocybin on aspects of cognition in healthy adult volunteers.
- Trial name
- NCT07818564
- Testing
- Psilocybin (Usona Institute)
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Brown University
Healthy
The Acute Effects of Psilocybin on Cognition, Memory, and Brain Function
This study will test the effects of psilocybin on memory and cognition in healthy participants using computerized tasks and magnetic resonance imaging (MRI).
- Trial name
- NCT07079852
- Testing
- Psilocybin 15mg
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Manoj Doss
Healthy
Digital Intervention for Psychedelic Preparation (DIPP): Comparing Meditation and Music-Based Programs
This randomised controlled feasibility trial evaluates the Digital Intervention for Psychedelic Preparation (DIPP), a novel 21-day self-guided program designed to prepare individuals for psychedelic experiences.
- Trial name
- (DIPP-RCFT) (NCT06815653)
- Testing
- Psilocybin 25mg
- Where
- United Kingdom
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University College, London